Method and device for sampling and storing urine specimen

ABSTRACT

A method and a device for sampling and storing a urine specimen capable of recovering a sampled urine specimen to a recovery container ( 5 ) through a filter ( 2 ) by the sucking pressure of the decompressed and enclosed recovery container ( 5 ); the device for sampling and storing the urine specimen, comprising a filter holder ( 3 ) having a space for storing the filter ( 2 ) for filtrating the urine specimen, the filter ( 2 ) stored therein, and the recovery container ( 5 ) decompressed and enclosed by a plug body ( 4 ), wherein hollow tubes ( 6 ) with a sharp tip communicating with a space (S) having the filter ( 2 ) stored therein is installed in the filter holder ( 3 ) on a specimen delivery side to the recovery container ( 5 ).

TECHNICAL FIELD

[0001] The present invention relates to a method and a device forenabling a long-time storage of a sampled urine specimen preventingchange in its property for urinalysis in the field of clinicaldiagnosis.

BACKGROUND INFORMATION

[0002] Urinalysis is broadly conducted as a screening test in a firstexamination for outpatients and a group examination and as a common testin observation of progress because in which it is possible to examinepatients without giving them a load at the moment of sampling aspecimen.

[0003] Since urine specimens sampled from patients are changed byexogenous and endogenous germs, oxygen and light comparatively soon,they had better be tested within 3-4 hours after being sampled. Whenurine specimens are left untested for more than 3-4 hours after beingsampled, they need to be hermetically kept in a refrigerator or afreezer. In a group examination where a large volume of urine specimensmust be tested, specimens are usually kept refrigerated or frozen, andput back to their normal condition at the time of examination.

[0004] However, while being let to stand in ambient air, sampledspecimens, in which germs could be propagated by exogenous andendogenous germs, could be changed in their constituents.

[0005] Furthermore, some constituents of urine specimens are sosensitive to oxygen and light that leaving them in ambient air couldcause an inaccurate test.

[0006] Especially, when many specimens are tested in a groupexamination, an inefficient way have to be chosen; for example, samplersand testing devices have to be continuously at work for a prompt test,or urine specimens must be hermetically kept in a refrigerator or afreezer, and defrosted before a test.

[0007] Moreover, urine specimens sampled in regions and facilities whereno testing equipment is available are inevitably required not only to beairtightly kept in a refrigerator or a freezer, but also to be sent inthe same conditions to another facility for a test using uneconomicaltransportation.

[0008] It is therefore an object of the present invention to solve theconventional problems mentioned above and to provide a method and adevice for sampling and storing a urine specimen, which allow accuratetesting of sampled specimens preventing change in constituents evenafter a several-day storage at room temperature, and easy transportationof sampled specimens collected in a group examination withoutrefrigeration or other treatment.

SUMMARY OF THE INVENTION

[0009] A method for sampling and storing a urine specimen according tothe present invention includes filtering a sampled urine specimenthrough a filter, decompressing and sealing a recovery container, andrecovering the sampled urine specimen into the recovery container usingsucking pressure therein.

[0010] A device for sampling and storing a urine specimen according tothe present invention includes a sampling cup, a filter for a urinespecimen, a filter holder for holding the filter, a plug, a recoverycontainer decompressed and sealed with the plug. The filter holder has aspace to hold the filter inside and tubes with sharp tips respectivelycommunicating with the space at both of its outlet and inlet sides for aspecimen.

[0011] The filter holder, which has the space to hold the filter inside,may have a communicating hole communicating with a bottom hole of thesampling cup at its inlet side for a specimen and a tube with a sharptip communicating with the space of the filter holder at its outletside.

[0012] Furthermore, a device for sampling and storing a urine specimenaccording to the present invention includes a filter for a urinespecimen, a filter holder receiving the filter, a plug, a recoverycontainer decompressed and sealed with the plug. The filter holder isprovided with a space for holding the filter, an outer cover extendingupward on its outlet side for a specimen, a tube with a sharp tipcommunicating with the space within the outer cover, and a specimensuction tube communicating with the space on its inlet side of thespecimen. The recovery container is insertable into the outer cover ofthe filter holder with the plug ahead.

[0013] In the device for sampling and storing a urine specimen accordingto the present invention, the filter holder favourably has a pore sizeof 0.05 μm-0.2 μm.

[0014] And also, in the device for sampling and storing a urine specimenaccording to the present invention, the recovery container does notfavourably transmit light.

[0015] Furthermore, in the device for sampling and storing a urinespecimen according to the present invention, the pressure in therecovery container is favourably 0.1 atm-0.5 atm, and the recoverycontainer is favourably decompressed and sealed after being filled withinert gas.

[0016] The above-mentioned method and device allow removing germs from asampled and stored urine specimen by filtering so as to preventconstituents from being changed by germ contamination and influence ofoxygen and light, and a long-time storage without refrigeration or othertreatment.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1 is a sectional view of an embodiment of a device forsampling and storing a urine specimen according to the presentinvention.

[0018]FIG. 2 is a sectional view of the device for sampling and storinga urine specimen according to the present invention in FIG. 1, which isin use.

[0019]FIG. 3 is a sectional view of another embodiment of a device forsampling and storing a urine specimen according to the presentinvention.

[0020]FIG. 4 is a sectional view of the device for sampling and storinga urine specimen according to the present invention in FIG. 3, which isin use.

[0021]FIG. 5 is a perspective view of another embodiment of a device forsampling and storing a urine specimen according to the presentinvention.

[0022]FIG. 6 is a sectional view of the device for sampling and storinga urine specimen according to the present invention in FIG. 5.

[0023]FIG. 7 is a perspective view of the device for sampling andstoring a urine specimen according to the present invention in FIG. 5,which is in use.

[0024]FIG. 8 is a perspective view of the device for sampling andstoring a urine specimen according to the present invention in FIG. 5,which is in use.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0025] Embodiments according to the present invention are described indetail below in conjunction with the accompanying drawings.

[0026] A device for sampling and storing a urine specimen of the presentinvention, as shown in FIGS. 1 and 3, includes a sampling cup 1 tosample urine, a filter 2 for a urine specimen, a filter holder 3 holdingthe filter 2, a plug 4, and a recovery container 5 decompressed andsealed with the plug 4.

[0027] In FIG. 1, the filter holder 3 has a space S1 holding the filter2 inside. The space S1 is provided with needles 6 respectively on anupper inlet and a lower outlet sides for a specimen, and the needles arein the form of a tube with a sharp tip and respectively communicatingwith the space S1. A thin rubber cap 7 covers around the needle 6 so asto prevent sampled urine from leaking out and/or avoid a user's injurysuch as pricking his or her fingers with the needle.

[0028] With the device for sampling and storing a urine specimen asshown in FIG. 1, the method for sampling and storing a urine specimen iscarried out, as follows. As shown in FIG. 2, the needle 6 attached atthe top of the filter holder 3 pierces the bottom 1 a of the samplingcup 1 of a sampled urine specimen through the rubber cap 7, and theother needle 6 attached the bottom of the filter holder 3 pierces theplug 4 of the decompressed and sealed recovery container 5 through therubber cap 7 alike. Consequently, a urine specimen sampled in thesampling cup 1 flows into the recovery container 5 through the filter 2by sucking pressure to be recovered.

[0029] In FIG. 3, the filter holder 3 has a space S1 for holding thefilter 2 inside, a communicating hole 8 at its upper inlet side for aspecimen and a needle 6 at its lower outlet side for a specimen. Thecommunicating hole 8 is communicating with a bottom hole lb of thesampling cup 1, and the needle 6 is communicating with the space S1 ofthe filter holder 3. A rubber cap 7 covers around the needle 6 so as toavoid a user's injury such as pricking his or her fingers with theneedle the same as in FIG. 1. Additionally, a space S2, wherein thefilter holder 3 can be held, is provided at the bottom of the samplingcup 1 to prevent the filter holder 3 from projecting over the bottom ofthe sampling cup 1.

[0030] Therefore, as shown in FIG. 4, in order to carry out the methodfor sampling and storing a urine specimen with the device for samplingand storing a urine specimen according to FIG. 3, the needle 6 attachedat the bottom of the filter holder 3 pierces the plug 4 of thedecompressed and sealed recovery container 5 through the rubber cap 7,and the urine specimen sampled in the sampling cup 1 consequently flowsinto the recovery container 5 through the filter 2 by sucking pressureto be recovered.

[0031] As long as the sampling cup 1 can be pierced by the needle 6 torecover a urine specimen without an excessive leak of the specimen,neither its shape nor materials is limited.

[0032] Furthermore, another device for sampling and storing a urinespecimen of the present invention, as shown in FIG. 5, includes a filter2 for a urine specimen, a filter holder 3 holding the filter 2, a plug4, and a recovery container 5 decompressed and sealed with the plug 4.

[0033] The filter holder 3 has a space S to hold the filter 2 inside, anouter cover 3 a extending upward on its outlet side for a specimen, aneedle 6 within the outer cover 3 a, and a specimen suction tube 9 atits lower inlet side for a specimen. The needle 6 and the specimensuction tube 9 are communicating with the space S. In order to make thespecimen suction tube 9 communicate with the space S, the specimensuction tube 9 is communicating with a communicating hole 10 a of a cap10 which seals the space S from below. A manipulation flange 11 isattached around the outer cover 3 a.

[0034] The recovery container 5 is insertable into the outer cover 3 aof the filter holder 3 with the plug 4 ahead.

[0035] As shown in FIGS. 5 and 6, in the above-mentioned device forsampling and storing a urine specimen according to the presentinvention, the recovery container 5 is put into the outer cover 3 a ofthe filter holder 3 with the plug 4 ahead to in front of the needle 6.Then as shown in FIG. 7, the specimen suction tube 9 is put into theurine specimen sampled in a sampling container U or the like, and therecovery container 5 is inserted into the outer cover 3 a of the filterholder 3 even deeper to make the needle pierce the plug 4. Consequently,the urine specimen sampled in the sampling container U or the like flowsfrom the specimen suction tube 9 into the recovery container 5 throughthe filter 2 by sucking pressure. Furthermore, as shown in FIG. 8, therecovery container 5 is drawn out of the filter holder 3, andconsequently, the needle 6, which has pierced the plug 4 is drawntherefrom. And the urine specimen is sampled and stored in the recoverycontainer 5.

[0036] In the above-mentioned operation, the recovery container 5 can beeasily inserted into the outer cover 3 a of the filter 3 and also easilydrawn therefrom because of the manipulation flange 11.

[0037] The specimen suction tube 9 can be made of glass or plastics, andit does not matter whether the specimen suction tube 9 is flexible ornot. The inside diameter is not limited as long as it does not hinder aurine specimen from flowing into the decompressed and sealed recoverycontainer 5 by sucking pressure.

[0038] In the above-mentioned embodiment, the filter 2 held within thefilter holder 3 is favourably made of cellulose acetate, polysulfone, orpolyether sulfone, which have low adsorptivity for constituents of urinesuch as protein, and the pore size is favourably 0.05 μm-0.2 μm in orderto enable a urine specimen to be smoothly filtered but not germs.

[0039] The recovery container 5 has material and structure that shut outthe air, and it is sealed with the plug 4 made of synthetic rubber orthe like after being decompressed by being filled with inert gas such asnitrogen gas. The recovery container 5 needs to be decompressed enoughto be able to recover an adequate amount of specimen. Although itdepends on material, the pressure in the recovery container 5 isfavourably 0.1 atm-0.5 atm because extreme decompression affectsefficiency of keeping the pressure and durability of the container.

[0040] The size and sharp of the recovery container 5 are favourablylike of a test tube or a bottle which can be put on a common device fora urine test, but not limited. In FIG. 5, they are not limitative aslong as the recovery container 5 is insertable into the filter holder 3with the plug 4 ahead. Furthermore, it is advisable that the recoverycontainer 5 does not transmit light so that effect of light on a sampledurine specimen can be reduced.

[0041] As shown in FIG. 6, the plug 4 of the recovery container may beprovided with a recess on an upper and/or a lower side thereof, and therecess provides a thinner portion on the plug. Therefore, the needle caneasily pierce the plug at the thinner portion and can be readily drawntherefrom, and still the plug maintains durability againstdecompression.

[0042] Specific Examples of Operation of Invention

[0043] The present invention is concretely described, referring to thefollowing specific examples.

[0044] With the device for sampling and storing a urine specimen of thepresent invention according to FIG. 3, the method for sampling andstoring a urine specimen of the present invention was operated, and theconstituents of the urine specimens were determined after 0-7 days.

[0045] First of all, the urine specimens A-E were taken into thesampling cups 1 respectively. Next, the needles 6 each attached at thebottom of the filter holders 3 were pierced the plugs 4 of thedecompressed and sealed recovery containers 5. Then the urine specimens,which had been sampled in the sampling cups 1, flowed through filters 2into the recovery containers 5 by sucking pressure. After that, theneedles 6 which had been pieced the plug 4 were drawn therefrom, and thecontainers were kept at room temperature for 0-7 days, being sealed withthe plugs 4. The filters 2 were made of cellulose acetate by AdvantechCo., Ltd. Their pore sizes were 0.2 μm, and their diameters were 50 mm.The recovery containers 5 were brown plastic test tubes which weredecompressed to 0.2 atm and were sealed with rubber plugs.

[0046] In contrast, as examples for comparison, the rest of the urinespecimens A-E which had been collected in the above-mentioned samplingcups were recovered into brown plastic test tubes and let to stand atroom temperature for 0-7 days.

[0047] The constituents of the specimens were determined by a urine testinstrument (US-3100) made by Eiken Chemical Co., Ltd. shortly afterstarting storing, 2 days, 4 days and 7 days respectively. The results ofthe determination are shown in Tables 1-5. TABLE 1 Examples ComparativeExamples shortly shortly after after starting after 2 after 4 after 7starting after 2 after 4 after 7 storing days days days storing daysdays days Specimen colour yellow yellow yellow yellow yellow yellowyellow straw A gravity 1.008 1.010 1.010 1.012 1.012 1.008 1.009 1.007pH 6.0  6.0  6.0  6.0  6.0  6.5  7.0  7.5  sugar — — — — — — — — protein— — — — — — — — ketones — — — — — — — — bilirubin — — — — — — — —urobilinogen ± ± ± ± ± ± ± ± nitrite — — — — — — — 1+   glucose — — — —— — — — (mg/dl)

[0048] TABLE 2 Examples Comparative Examples shortly shortly after afterstarting after 2 after 4 after 7 starting after 2 after 4 after 7storing days days days storing days days days Specimen colour yellowyellow yellow yellow yellow straw straw straw B gravity   1.038   1.036  1.039   1.039   1.039   1.036   1.038   1.035 pH   7.0   7.0   7.0  7.0   7.0   7.5   8.0   8.5 sugar   4+   4+   4+   4+   4+   4+   4+  4+ protein   1+   1+   1+   1+   1+   1+ — — ketones   1+   1+   1+  1+   1+ — — — bilirubin — — — — — — — — urobilinogen ± ± ± ± ± ± ± ±nitrite — — — — — — 1+ 2+ glucose 6,200 6,188 6,219 6,182 6,253 6,1856,077 5,882 (mg/dl)

[0049] TABLE 3 Examples Comparative Examples shortly shortly after afterstarting after 2 after 4 after 7 starting after 2 after 4 after 7storing days days days storing days days days Specimen colour strawstraw straw straw straw straw straw amber C gravity  1.022  1.023  1.023 1.021  1.024  1.023  1.025  1.023 pH  6.0  6.0  6.0  6.0  6.0  6.0  7.0 8.0 sugar  2+  2+  2+  2+  2+  2+  1+  1+ protein — — — — — — — —ketones — — — — — — — — biliruhin — — — — — — — — urobilinogen ± ± ± ± ±± ± ± nitrite — — — — —  1+  1+  2+ glucose 116 112 118 120 117 114 7548 (mg/dl)

[0050] TABLE 4 Examples Comparative Examples shortly shortly after afterstarting after 2 after 4 after 7 starting after 2 after 4 after 7storing days days days storing days days days Specimen colour strawstraw straw straw straw straw amber amber D gravity  1.031  1.033  1.028 1.030  1.030  1.028  1.031  1.030 pH  7.5  7.5  7.5  7.5  7.5  8.0  8.5 8.5 sugar  3+  3+  3+  3+  3+  3+  3+  2+ protein  2+  2+  2+  2+  2+ 2+  1+  1+ ketones — — — — — — — — bilirubin — — — — — — — —urobilinogen ± ± ± ± ± ± ± ± nitrite  1+  1+  1+  1+  1+  2+  2+  2+glucose 558 567 535 563 563 446 283 158 (mg/dl)

[0051] TABLE 5 Examples Comparative Examples shortly shortly after afterstarting after 2 after 4 after 7 starting after 2 after 4 after 7storing days days days storing days days days Specimen colour yellowyellow yellow yellow yellow yellow straw straw E gravity  1.018  1.015 1.014  1.017  1.015  1.018 1.016 1.015 pH  6.5  6.5  6.5  6.5  6.5  7.07.0 7.5 sugar  1+  1+  1+  1+  1+ — — — protein  1+  1+  1+  1+  1+  1+— — ketones  2+  2+  2+  2+  2+  1+ — — bilirubin  1+  1+  1+  1+  1+ —— — urobilinogen  1+  1+  1+  1+  1+ ± ± ± nitrite — — — — —  1+ 1+ 2+glucose 38 47 42 44 48 25 — — (mg/dl)

[0052] As the results shown in Tables 1-5, in the comparative examples,there were big fluctuations in some testing items such as colour,gravity, pH, sugar, protein and nitrite during 1-7 days, but in theexamples, no fluctuation was found in the above items during 1-7 days.

[0053] Furthermore, with the device for sampling and storing a urinespecimen of the present invention according to FIG. 5, urine specimenswere sampled and stored, and their constituents were determined shortlyafter starting storing and after 7 days.

[0054] First of all, the urine specimens F-J were taken into samplingcontainers U or the like. Next, the specimen suction tubes 9 of thefilter holders 3 were respectively put into the urine specimens F-Jwhile the recovery containers 5 were inserted into the outer covers 3 awith the plugs 4 ahead to in front of the needles 6. Then the recoverycontainers 5 were inserted into the outer covers 3 a of the filterholders 3 even deeper to make the needles 6 pierce the plugs 4.Consequently, the urine specimens F-J respectively flowed from thespecimen suction tubes 9 through the filters 2 into the recoverycontainers 5 by sucking pressure to be recovered. After that, therecovery containers 5 were drawn out of the filter holders 3, andconsequently the needles 6 which had been pierced the plugs 4 were drawntherefrom, and the containers were kept at room temperature for 0-7 daysbeing sealed with the plugs 4. The filters 2 were made of celluloseacetate by Advantech Co., Ltd. Their pore sizes were 0.2 μm, and theirdiameters were 50 mm. The recovery containers 5 were brown plastic testtubes which were decompressed to 0.2 atm and sealed with rubber plugs.

[0055] In contrast, as examples for comparison, the rest of the urinespecimens F-J were collected in brown plastic test tubes and let tostand at room temperature for 7 days.

[0056] The constituents of the specimens were determined by a urine testinstrument (US-3100) made by Eiken Chemical Co., Ltd. shortly afterstarting storing and after 7 days respectively. The results of thedetermination are shown in Table 6. TABLE 6 Comparative ExamplesExamples pH sugar protein pH sugar protein Specimen A shortly after 6.0— — 6.0 — — starting storing after 7 days 6.0 — — 7.5 — — Specimen Bshortly after 7.0 6,200 1+ 7.0 6,253 1+ starting storing after 7 days7.0 6,182 1+ 8.5 5,822 — Specimen C shortly after 6.0 116 — 6.0 117 —starting storing after 7 days 6.0 120 — 8.0 48 — Specimen D shortlyafter 7.5 558 2+ 7.5 563 2+ starting storing after 7 days 7.5 563 2+ 8.5158 1+

[0057] Since the present invention is composed as mentioned above, evenif urine specimens are kept at room temperature for several days,constituents of urine specimens will not be changed, and accuratedetermination can be obtained. Also, in a group examination, urinespecimens can be easily transported and tested without refrigeration orother treatment.

[0058] Furthermore, the device for sampling and storing a urine specimenof the present invention has a simple structure and can be easily used,and additionally a sampler does not need to touch a needle directly.Therefore, the device allows safe and easy sampling and testing in aregion without enough equipment.

What is claimed is:
 1. (amended) A method for sampling and storing aurine specimen comprising: filtering a sampled urine specimen to removegerms therefrom through a filter (2) which has a pore size of 0.05μm-0.2 μm; decompressing and sealing a recovery container; andrecovering the sampled urine specimen into the recovery container usingsucking pressure therein.
 2. (amended) A method for sampling and storinga urine specimen according to claim 1, in which the recovery container(5) does not transmit light.
 3. (amended) A method for sampling andstoring a urine specimen according to claim 1, in which pressure in therecovery container (5) is 0.1 atm-0.5 atm.
 4. (amended) A method forsampling and storing a urine specimen according to claim 1, in which therecovery container (5) is decompressed and sealed after being filledwith inert gas.
 5. (amended) A device for sampling and storing a urinespecimen comprising: a sampling cup (1); a filter (2) for a urinespecimen; a filter holder (3) for holding the filter (2); a plug (4); arecovery container (5) decompressed and sealed with the plug (4); andwherein the filter holder (3) has a space (S1) to hold the filter (2)inside and tubes (6) with sharp tips respectively communicating with thespace (S1) at both of its outlet and inlet sides for a specimen. 6.(amended) A device for sampling and storing a urine specimen comprising:a sampling cup (1); a filter (2) for a urine specimen; a filter holder(3) for holding the filter (2); a plug (4); a recovery container (5)decompressed and sealed with the plug (4); and wherein the filter holder(3) has a space (S1) to hold the filter (2) inside, a communicating hole(8) communicating with a bottom hole (1 b) of the sampling cup (1) atits inlet side for a specimen, and a tube (6) with a sharp tipcommunicating with the space (S1) of the filter holder (3) at its outletside.
 7. (amended) A device for sampling and storing a urine specimenaccording to any one of claims 5 and 6, in which the filter (2) has apore size of 0.05 μm-0.2 μm.
 8. (amended) A device for sampling andstoring a urine specimen comprising: a filter (2) for removing germsfrom a sampled urine specimen, the filter (2) having a pore size of 0.05μm-0.2 μm; a filter holder (3) which has a space S for receiving thefilter (2); a plug (4); a recovery container (5) decompressed and sealedwith the plug (4); and wherein the filter holder (3) is provided withthe space (S) for holding the filter (2), an outer cover (3 a) extendingupward on its outlet side for a specimen, a tube (6) with a sharp tipcommunicating with the space (S) within the outer cover (3 a), and aspecimen suction tube (9) communicating with the space (S) on its inletside for the specimen, and the recovery container (5) is insertable intothe outer cover (3 a) of the filter holder (3) with the plug (4) ahead.9. (amended) A device for sampling and storing a urine specimenaccording to any one of claims 5, 6 and 8, in which the recoverycontainer (5) does not transmit light.
 10. (amended) A device forsampling and storing a urine specimen according to any one of claims 5,6 and 8, in which pressure in the recovery container (5) is 0.1 atm-0.5atm.
 11. (amended) A device for sampling and storing a urine specimenaccording to any one of claims 5, 6 and 8, in which the recoverycontainer (5) is decompressed and sealed after being filled with inertgas
 12. (deleted)